GW Pharmaceuticals plc Reports 2013 Q4 and Full Year Financial Results

LONDON, Nov. 19, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announces its preliminary results for the fourth quarter and the year ended 30 September 2013.  

2013 HIGHLIGHTS:

• Initial public offering on the NASDAQ Global Market completed in May 2013 raising total net proceeds before expenses of $30.7m (£19.8m)
• Two U.S.-targeted Sativex^® Phase 3 pivotal programs advanced in 2013
  • Cancer Pain: two pivotal Sativex Phase 3 trials in recruitment
    • First Phase 3 top-line results expected in H2 2014
    • Data intended to lead to a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA)
  • Multiple Sclerosis (MS): Phase 3 Investigational New Drug (IND) application opened with the FDA for Sativex in the treatment of MS spasticity
    • Special Protocol Assessment (SPA) to be requested prior to anticipated start of Phase 3 trial in 2014
  • All Sativex Phase 3 clinical trials targeted at FDA approval are fully funded by U.S. partner, Otsuka
  • Sativex U.S. patent position further strengthened through two additional U.S. Notices of Allowance
• Sativex now approved in 22 countries (ex-U.S) as a treatment for MS spasticity
  • In-market sales by partners increased by 25%
  • Commercial launch in Italy in July 2013
  • Germany pricing agreement reached in September 2013
  • Recommendation for approval in France in October 2013
  • On-going commercial launches in planning over next 12 months
  • New Sativex data presented at ECTRIMS in October 2013
• Expansion of epilepsy research program through commencement of a new orphan pediatric epilepsy program for Epidiolex^® (purified extract of Cannabidiol, or CBD)
  • FDA orphan drug designation granted by FDA for Epidiolex in Dravet syndrome
  • Seven physician-led INDs granted by FDA to treat 125 pediatric epilepsy patients in the U.S. with Epidiolex
  • Epidiolex pediatric epilepsy clinical trials in planning for 2014
  • Additional epilepsy pipeline candidate, GWP42006 (Cannabidivarin or CBDV), commenced Phase 1 trial in September 2013
• Significant clinical activity for GW's other cannabinoid pipeline product candidates, including:
  • Positive preliminary data reported from a Phase 2a exploratory clinical trial of the novel cannabinoid medicine GWP42004 in type-2 diabetes with a Phase 2 dose ranging trial expected to commence in early 2014
  • Phase 2 trial of GWP42003 for the treatment of ulcerative colitis on-going with data expected in the first half of 2014
  • Phase 2 trial of GWP42003 for the treatment of schizophrenia expected to commence in the first half of 2014
  • Phase 1b/2a trial of THC:CBD for the treatment of glioma commenced in November 2013

Financial Highlights

• Total revenue for 2013 of £27.3m ($44.2m) compared to £33.1m in 2012. 2012 revenues included a £9.8m milestone receipt compared to £0.3m milestone income in 2013.
• Net loss after tax for 2013 of £4.5m ($7.4m) compared to a profit after tax of £2.5m in 2012, which primarily reflected the impact of the £9.8m milestone payment received last year.
• Cash and cash equivalents at 30 September 2013 of £38.1m ($61.6m) compared to £29.3m as at 30 September 2012.

"This was a transformative year for GW with the successful completion of an IPO on NASDAQ, progress with two Phase 3 programs for Sativex in the United States, and the emergence of a new exciting orphan development program in childhood epilepsy," stated Justin Gover, GW's Chief Executive Officer. "We believe that the Company is poised to meet a number of significant clinical, regulatory and commercial milestones for GW investors. These include Phase 3 data from our U.S.-focused pivotal Sativex trials, further Sativex commercial launches and sales growth, progress of the new orphan epilepsy program in the U.S., and further advancement of several other cannabinoid pipeline candidates."

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2013 financial results today at 8:00 a.m. ET / 1:00 p.m. GMT. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0-800-756-3429 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company's website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13572702.

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional clinical-stage cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), type 2 diabetes, ulcerative colitis, glioma and schizophrenia. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding financial performance, timing of clinical trials and data, relevance of GW products commercially available and in development, size of market opportunities, and development and regulatory clearance of GW's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex^® and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

All activities relate to continuing operations.

The Group has no gains or losses other than those shown above and therefore no separate statement of recognised income and expense has been presented.

This announcement was approved by the Board of Directors on 18 November 2013.

SOURCE GW Pharmaceuticals plc